Multiple suture thread configuration with an intermediate connector

ABSTRACT

A suture system has a plurality of double ended barbed sutures each with a first plurality of barbs located adjacent to a first end and a second plurality of barbs located adjacent to a second end, and a body connector that connects said plurality of double ended barbed sutures. The body connector is located between the first plurality of barbs and the second plurality of barbs on each of the sutures. The sutures can move relative to the body connector. The body connector can retain tissue.

CLAIM TO PRIORITY

This application is a continuation of U.S. application Ser. No.12/119,749, filed May 13, 2008, which is a divisional of U.S.application Ser. No. 10/914,755, filed Aug. 9, 2004, now U.S. Pat. No.7,371,253, issued May 13, 2008; which is a divisional of U.S.application Ser. No. 10/216,516, filed Aug. 9, 2002, now U.S. Pat. No.6,773,450, issued Aug. 10, 2004. All of the above claimed priorityapplications are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

This invention relates generally to a device and method for anchoringtissue within a body and, more particularly, to a suture anchor for usein surgical procedures requiring attachment of tissue, such asligaments, tendons and the like, to other, preferably harder or morefibrous, tissue, such as a bone surface.

Suture anchors are used in surgical procedures wherein it is necessaryfor a surgeon to attach tissue to the surface of bone, for example,during joint reconstruction and ligament repair or replacement. Sutureanchors generally comprise an anchor portion for fixed attachment to thebone, and a suture portion extending from the anchor portion used toconnect the tissue to the bone. The anchor portion is often a generallycylindrical body having a sharp pointed end. An impact tool is typicallyused for driving the pointed end of the anchor into the bone. The outersurface of the anchor portion may be barbed or serrated to prevent thesuture anchor from being withdrawn from the bone. The outer surface ofthe anchor portion could also be threaded and a driver, turned by aconventional drill, used to seat the threaded anchor portion into thebone. The anchor portion may also be fitted into a hole formed in thebone.

With the anchor portion securely in the bone, the suture portion is usedfor securing the tissue to the bone. The procedure typically involvespassing a needle with the suture attached through the tissue. The tissueis advanced along the suture and tension is applied to the suture todraw the tissue tightly against the bone. The needle is removed and thetissue is secured against the bone by knotting the ends of the sutureextending from the tissue. The knot is brought down to the surface ofthe tissue and tightened sufficiently to secure the tissue and bone inclose approximation to promote reattachment and healing. A slidingretainer is sometimes used with the suture to pin the tissue against thebone.

There are other conventional suture anchors for attaching tissue tobone. For example, the anchor portion could take other forms including astaple which is driven into the bone surface with the suture positionedbetween the staple legs and the staple web fixing the suture to the bonesurface. Also, a pair of closely-spaced holes can be drilled in the bonefor passing the suture into one hole and out the other. However, theseprocedures are often difficult to perform, particularly in areas withlimited access, such as deep wounds.

Further, conventional methods for approximating tissue to bone using asuture are difficult and inefficient because the procedure requiresmanipulation of the suture for securing the tissue in place. This is atime-consuming part of most surgical procedures, particularly inmicrosurgery and endoscopic surgery where there is insufficient space toproperly manipulate the suture.

For the foregoing reasons, there is a need for an improved suture anchorfor use in surgical procedures. The new suture anchor should eliminatethe need for tying the suture to hold the tissue against the bone orother tissue surface. The method for using the suture anchor in surgicalapplications should allow a surgeon to approximate tissue to the bone ortissue surface in an efficient manner. A particularly useful new sutureanchor would be used in surgical applications where space is limitedsuch as microsurgery, endoscopic surgery or arthroscopic surgery.

SUMMARY OF THE INVENTION

According to the present invention, a suture anchor is provided forapproximating tissue to bone or other tissue. The suture comprises ananchor member adapted to fixedly engage the bone for securing the anchormember relative to the bone. A plurality of sutures are mounted to theproximal end of the anchor member so that the sutures extend outwardlyfrom the anchor member. Each suture has a sharp pointed distal end forpenetrating the tissue and a plurality of barbs extending from theperiphery of the body. The barbs permit movement of the sutures throughthe tissue in a direction of movement of the pointed end and preventmovement of the sutures relative to the tissue in a direction oppositethe direction of movement of the pointed end.

Also according to the present invention, a method is provided forapproximating tissue to a bone or other tissue to allow reapproximationand healing of the tissue and bone in vivo. The method uses a sutureanchor including an anchor member adapted to be fixedly mounted to thebone and a plurality of sutures extending from the anchor member. Themethod comprises the steps of providing on each suture a sharp pointeddistal end for penetrating the tissue and a plurality of barbs extendingfrom the periphery of the body. The barbs permit movement of the suturesthrough the tissue in a direction of movement of the pointed end andprevent movement of the sutures relative to the tissue in a directionopposite the direction of movement of the pointed end. The anchor memberis secured in the bone such that the sutures extend from the bonesurface and a pointed end of a first suture is inserted into the tissue.The end of the first suture is pushed through the tissue along acurvilinear path in a direction away from the bone until the point atthe end of the first suture extends out of the tissue at an exit pointin the periphery of the tissue longitudinally spaced from the point ofinsertion. The pointed end of the first suture is gripped and pulled outof the tissue for drawing the first suture through the tissue whileapproximating the tissue adjacent the bone along the suture and leavinga length of the first suture in the tissue. The pointed end of the firstsuture is then inserted into the periphery of the tissue adjacent theexit point and pushed through the tissue along a curvilinear path in thedirection away from the bone until the pointed end of the first sutureextends out of the tissue at an exit point in the periphery of thetissue longitudinally spaced from the previous insertion point. Thepointed end of the first suture is gripped and pulled out of the tissuefor drawing the first suture through the tissue leaving a length of thefirst portion of the suture in the tissue. These steps are repeated withthe first suture for advancing longitudinally along the tissue in thedirection away from the bone. A second suture is then introduced intothe tissue and the previous steps repeated so that the exit and entrypoints of the second suture are adjacent the corresponding exit andentry points of the first suture and the path of the second suturesubstantially mirrors the path of the first suture.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, referenceshould now be had to the embodiments shown in the accompanying drawingsand described below. In the drawings:

FIG. 1 is a perspective view of an embodiment of a suture anchoraccording to the present invention;

FIG. 2 is a perspective view of another embodiment of a suture anchorincluding a plurality of barbed sutures according to the presentinvention;

FIG. 3 is a side elevation view of an ankle with a portion of the outerlayer of tissue cut-away to schematically show a torn Achilles tendon;

FIGS. 4-6 are schematic views of an embodiment of a method according tothe present invention for reattaching the Achilles tendon to bone;

FIGS. 7-10 are perspective views of a method for joining two ends of asevered tendon according to the present invention;

FIGS. 11-13 are perspective, side and top plan views, respectively, ofthe suture pattern generated by the method shown in FIGS. 7-10;

FIGS. 14-17 are perspective views of another method for joining two endsof a severed tendon according to the present invention;

FIGS. 18 and 19 are perspective and side elevation views, respectively,of the suture pattern generated by the method shown in FIGS. 14-17; and

FIGS. 20 and 21 are side and rear elevation views, respectively, of theankle shown in FIG. 3 with the torn Achilles tendon reattached to thebone using the suture anchor and method shown in FIGS. 7-13 according tothe present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein, the term “tissue” includes tendons, ligaments,cartilage, muscle, skin, organs, and other soft tissue. The term “bone”includes bone, cartilage, tendon, ligament, fascia, and other connectiveor fibrous tissue suitable for anchor for a suture.

Certain other terminology is used herein for convenience only and is notto be taken as a limitation on the invention. For example, words such as“upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,”and “downward” merely describe the configuration shown in the FIGs. Itis understood that the components may be oriented in any direction andthe terminology, therefore, should be understood as encompassing suchvariations unless specified otherwise.

Referring now to the drawings, wherein like reference numerals designatecorresponding or similar elements throughout the several views, there isshown in FIG. 1 a suture anchor for use according to the presentinvention and generally designated at 30. The suture anchor 30 includesan anchor portion 32 and a suture portion 34. The anchor portion 32comprises an elongated body 36 having a distal pointed tip 38 whichserves as a leading end of the suture anchor 30 when the suture anchoris inserted into bone. A blind bore 40, or opening, is formed at theproximal end 41 of the anchor portion 32. A crossbar 42 integral withthe anchor body 36 spans the opening 40 for threadably receiving thesuture portion 34 at the proximal end of the anchor portion 32.

The anchor portion 32 is shown as having a circular cross-section,although other cross-sectional shapes could be utilized withoutdeparting from the present invention. As shown in FIG. 1, ridges 44, orbarbs, may be formed on the outer surface of the anchor portion 32 whichallow movement of the anchor portion 32 through bone in one directionbut which resist the withdrawal of the anchor portion 32 after theanchor portion has been implanted in the bone.

As described above, the anchor portion 32 is driven into the bonesurface, pointed tip 38 first, by impact against the proximal end 41, orby turning as when the anchor portion 32 is threaded (not shown). Theanchor portion 32 can also be disposed into a hole bored in the bone, inwhich case insertion can be accomplished with direct pressure or gentletapping on the proximal end 41 of the anchor portion 32. The ridges 44on the surface of the anchor body 36 grasp the bone rendering the anchorportion 32 substantially irremovable from the bone. Tension on thesuture portion 34 enhances this effect.

The suture portion 34 of the suture anchor 30 has an elongated body 46and a plurality of barbs 48 disposed along the length of the body 46.First and second ends 50, 52 of the suture body 46 terminate in points54, 56 for penetrating tissue. The body 46 of the suture portion 34 is,in one embodiment, circular in cross section. Suitable diameters for thebody 46 range from about 0.001 mm to about 5.0 mm. The body 46 of thesuture portion 34 could also have a non-circular cross-sectional shapewhich would increase the surface area of the body 46 and facilitate theformation of multiple barbs 48. The length of the suture portion 34 canvary depending on several factors, including the desired surgicalapplication, the type of tissue to be approximated to the bone, thelocation of the bone, and the like. A suture portion 34 of proper lengthis selected for achieving suitable results in a particular application.

The plurality of barbs 48 is axially-spaced along the body 46 of thesuture portion 34. The barbs 48 are oriented in one direction facingtoward the first end 50 of the suture body 46 for a first portion 58 ofthe length of the suture portion 34 and in an opposite direction facingthe second end 52 of the suture body 46 for a second portion 60 of thesuture portion 34. The point on the suture body 46 where the barbs 48change direction is preferably positioned adjacent the crossbar 42 atthe proximal end of the anchor body 36. The barbs 48 are yieldabletoward the body 46. The barbs 48 on each portion 58, 60 of the suturebody 46 are oriented so as to allow movement of the suture portion 34through the tissue in one direction along with the corresponding end 50,52 of the suture portion 34. The barbs 48 are generally rigid in anopposite direction to prevent the suture body 46 from moving in thetissue in the opposite direction.

The barbs 48 can be arranged in any suitable pattern, for example, in ahelical pattern as shown in FIG. 1. The number, configuration, spacingand surface area of the barbs 48 can vary depending upon the tissue inwhich the suture portion 34 is used, and depending on the compositionand geometry of the suture body 46. The proportions of the barbs 48 mayremain relatively constant while the overall length and spacing of thebarbs 48 are determined by the tissue being approximated to the bone.For example, if the suture portion 34 is intended to be used in tendon,the barbs 48 can be made relatively short and more rigid to facilitateentry into this rather firm, fibrous tissue. If the suture portion 34 isintended for use in soft tissue, such as fat, the barbs 48 can be madelonger and spaced farther apart to increase the holding ability in thesoft tissue. Moreover, the ratio of the number of barbs 48 on the firstportion 58 of the suture body 46 to the number of barbs 48 on the secondportion 60, and the lengths of each portion 58, 60, can vary dependingon the surgical application and needs.

The surface area of the barbs 48 can also vary. For example,fuller-tipped barbs 48 can be made of varying sizes designed forspecific surgical applications. For joining fat and relatively softtissues, larger barbs 48 are desired, whereas smaller barbs 48 are moresuited for collagen-dense tissues. There are also situations where acombination of large and small barbs 48 within the same structure willbe beneficial such as when the suture portion 34 is used in the repairof tissue with differing layered structures. Use of the combination oflarge and small barbs 48 with the same suture portion 34 wherein barb 48sizes are customized for each tissue layer will ensure maximum anchoringproperties.

The barbs 48 may be formed on the surface of the suture body 46according to any suitable method, including cutting, molding, and thelike. The preferred method is cutting with acute angular cuts directlyinto the suture body 46 with the cut portions pushed outwardly andseparated from the body 46. The depth of the barbs 48 formed in thesuture body 46 depends on the diameter of the suture material and thedepth of cut. Embodiments of a suitable cutting device for cutting aplurality of axially spaced barbs 48 on the exterior of suture filamentsare shown and described in U.S. patent application Ser. No. 09/943,733,entitled “Method Of Forming Barbs On A Suture And Apparatus ForPerforming Same”, which was filed on Aug. 31, 2001, the contents ofwhich are hereby incorporated by reference. This cutting device utilizesa cutting bed, a cutting bed vise, a cutting template, and a bladeassembly to perform the cutting. When operated, the cutting device hasthe ability to produce a plurality of axially spaced barbs 48 in thesame or random configuration and at different angles in relation to eachother. Various other suitable methods of cutting the barbs 48 have beenproposed including the use of a laser. The barbs 48 could also be cutmanually. However, manually cutting the barbs 48 is labor intensive,decreases consistency, and is not cost effective. The suture portion 34could also be formed by injection molding, extrusion, stamping and thelike.

Barbed sutures suitable for use according to the methods of the presentinvention are described in U.S. Pat. No. 5,342,376, entitled “InsertingDevice for a Barbed Tissue Connector”, U.S. Pat. No. 6,241,747, entitled“Barbed Bodily Tissue Connector”, and U.S. Pat. No. 5,931,855. Thecontents of U.S. Pat. No. 5,342,376, U.S. Pat. No. 5,931,855 and U.S.Pat. No. 6,241,747 are hereby incorporated by reference.

The suture portion 34 is attached to the proximal end of the anchorportion 32. As seen in FIG. 1, the suture portion 34 is threaded aroundthe crossbar 42 on the anchor body 36. It is understood that the sutureportion 34 may be attached to the anchor portion 32 in a number of ways,including inserting the end of the suture body 46 into the bore 40formed in the proximal end of the anchor body 36 and securing the suturebody 46 in place with a set screw, rivet, or the like, or, wherein thematerial of the anchor portion 32 is metal, by swaging or crimping. Theanchor portion 32 and suture portion 34 could also be formed in onepiece in the manufacturing process. However, the preferred attachment ofthe suture portion 34 is as shown in FIG. 1 since this arrangementallows a simple, secure threading of a double-ended suture portion 34during manufacture or prior to use. Moreover, as seen in FIG. 2, theuser may selectively attach several suture portions 34 to the anchorportion 32 depending upon the surgical application.

Suitable material for the body 46 of the suture portion 34 is availablein a wide variety of monofilament suture material. The particular suturematerial chosen depends on strength and flexibility requirements. In oneembodiment, the material for the suture body 46 is flexible andsubstantially nonresilient so that the shape of an inserted sutureportion 34 will be determined by the path of insertion and thesurrounding tissue. In some applications, however, it may be desirablefor at least a portion of the suture body 46 to have sufficientdimensional stability to assume a substantially rigid configurationduring use and sufficient resiliency to return to a predeterminedposition after deflection therefrom. The portions of the ends 50, 52 ofthe suture body 46 adjacent the points 54, 56 may be formed of amaterial sufficiently stiff to enable the points 54, 56 to penetratetissue in which the suture portion 34 is used when a substantially axialforce is applied to the body 46. Variations in surface texture of thesuture body 46 can impart different interaction characteristics with thetissue.

The ends 50, 52 of the suture portion 34 may be straight (FIG. 1) orcurved (FIG. 2). In one embodiment, the ends 50, 52 of the sutureportion 34 may be surgical needles secured at each end of the sutureportion 34 so that the body 46 extends between the shank ends of the twoneedles. The needles are preferably constructed of stainless steel orother surgical-grade metal alloy. The needles may be secured to thesuture body 46 by means of adhesives, crimping, swaging, or the like, orthe joint may be formed by heat shrinkable tubing. A detachableconnection may also be employed such that the needles may be removedfrom the suture body 46 by a sharp tug or pull or by cutting. The lengthof the needles is selected to serve the type of tissue being repaired sothat the needles can be completely removed leaving the suture body 46 inthe desired position within the tissue.

The suture anchor 30 of the present invention can be formed of abioabsorbable material which allows the suture anchor 30 to be absorbedby the body over time. Bioabsorbable material is particularly useful inarthroscopic surgery and procedures. Many compositions useful asbioabsorbable materials can be used to make the suture anchor 30.Generally, bioabsorbable materials are thermoplastic polymers. Selectionof the particular material is determined by the desired absorption ordegradation time period which depends upon the anticipated healing timefor the subject of the procedure. Biodegradable polymers and co-polymersrange in degradation time from about one month to over twenty-fourmonths. They include, but are not limited to, polydioxanone,polylactide, polyglycolide, polycaprolactone, and copolymers thereof.Other copolymers with trimethylene carbonate can also be used. Examplesare PDS II (polydioxanone), Maxon (copolymer of 67% glycolide and 33%trimethylene carbonate), and Monocryl (copolymer of 75% glycolide and25% caprolactone). Germicides can also be incorporated into the sutureanchor 30 to provide long lasting germicidal properties.

Alternatively, either the anchor portion 32 or the suture portion 34 ofthe suture anchor 30 can be formed from non-absorbable material such as,for example, nylon, polyethylene terephthalate (polyester),polypropylene, and expanded polytetrafluoroethylene (ePTFE). The suturebody 46 can also be formed of metal (e.g. steel), metal alloys, or thelike. Titanium is a preferred material when the anchor portion 32 is toremain permanently in the bone. A suitable anchor portion 32 for useaccording to the present invention is available from Mitek Products ofNorwood, Mass. Alternatively, the anchor portion 32 can also be a rigidbarbed structure made from thick monofilament suture material with barbssuitable for anchoring in bone.

In use in an orthopedic surgical procedure, the anchor portion 32 of thesuture anchor 30 of the present invention is inserted into bone. Oncethe anchor portion 32 is fixed in place, the suture portion 34 extendsoutwardly from the anchor portion 32 and the bone for surgical suturingto tissue to be approximated to the bone. The tissue is brought intoposition over the suture anchor 30 site. The point 54 at one end 50 ofthe suture portion 34 is inserted into the tissue such that the point 54pierces the tissue and the barbs 48 on the portion 58 of the suture body46 corresponding to the one end 50 yield toward the body 46 tofacilitate movement of the suture body as it is drawn through the tissuein the direction of insertion. The point 56 at the other end 52 of thesuture portion 34 is also inserted into the tissue and advanced throughthe tissue in like manner. The tissue is then advanced along the sutureportions 58, 60 within the tissue to close the gap between the tissueand the bone. The barbs 48 of the suture body 46 grasp the surroundingtissue and maintain the tissue in position adjacent to the bone duringhealing. The leading ends 50, 52 of the suture body 46 protruding fromthe tissue are then cut and discarded.

According to the present invention, a surgical procedure using thesuture anchor 30 is provided for approximating a torn Achilles tendon tobone for reattachment and healing. It is understood that the applicantsdo not intend to limit the suture anchor 30 and method of the presentinvention to only the reattachment of the Achilles tendon.

Referring to FIG. 3, a human foot 70 is shown with a portion of theouter layer 72 of skin and tissue cutaway to schematically show theAchilles tendon 74 torn away from the heel bone 76. In this embodimentof the present invention, the user, such as a surgeon, selects a sutureanchor 30 (FIG. 4) having a suture portion 34 of sufficient length andhaving curved ends 50, 52 which, in one embodiment, as noted above maybe surgical needles. As seen in FIG. 4, the surgeon begins by insertingthe suture anchor 30 into the heel bone 76. The first and secondportions 58, 60 of the elongated suture portion 34 extend from theanchor portion 32. Next the surgeon inserts the first end 50 (FIG. 5),or surgical needle, into the free end of the Achilles tendon 74 andpushes the needle 50 through the tendon 74 along a selected curvilinearpath until the point 54 at the first end of the needle 50 extends froman exit point 78 at the periphery of the tendon 74 longitudinally spacedfrom the end of the tendon. The surgeon grips the needle 50 and pullsthe needle out of the tendon 74 for drawing the first portion 58 of thesuture body 46 through the tendon 74 leaving a length of the firstportion 58 of the suture body 46 in the tendon 74 between the end of thetendon and the exit point 78, as seen in FIG. 6. These steps arerepeated with the second portion 60 of the suture body 46 beginning withinsertion into the end of the tendon 74.

Methods according to the present invention useful in binding togetherpartially or completely severed tendons, or other internal tissuerepairs requiring considerable tensile strength, are suitable for use inattaching tissue to bone. One such method for joining two ends 82, 84 ofa tendon 80 is shown in FIGS. 7-10. Referring to FIG. 7, the surgeonbegins by inserting a first end 92 of a two-way barbed suture 90, whichmay comprise a straight or curved surgical needle, into one end 82 ofthe tendon 80 and pushing the needle 92 through the tendon 80 along aselected curvilinear path until the point 94 of the needle 92 extendsfrom an exit point 96 in the periphery of the tendon 80 longitudinallyspaced from the one end 82 of the tendon 80. The first needle 92 isgripped and pulled out of the tendon 80 for drawing a first portion 98of the suture 90 through the tendon 80 leaving a length of the firstportion 98 of the suture 90 in the tendon end 82 between the end of thetendon 80 and the exit point 96. As seen in FIG. 7, these steps arerepeated with a second portion 100 of the suture 90 at the other end 84of the tendon 80, wherein a second end 93 of the suture 90 is insertedinto the tendon end 84 and advanced along a selected curvilinear path toan exit point 97 longitudinally spaced from the end 84 of the tendon 80.The second end 93 of the suture 90 projecting from the exit point 97 isgripped and pulled out of the tendon 80 for drawing the second portion100 of the suture 90 through the tendon 80 and leaving a length of thesecond portion 100 of the suture 90 in the tendon end 84 (FIG. 8).

Referring now to FIG. 8, a second suture 90 a is introduced into theends 82, 84 of the tendon 80. The first needle 92 a of the second suture90 a is inserted into the one end 82 of the tendon 80 and pushed throughthe tendon along a selected curvilinear path until the needle 92 aextends from an exit point 96 a in the periphery of the tendon 82substantially co-located with the first exit point 96 of the firstportion 98 of the first suture 90. These steps are repeated with thesecond portion 100 a of the second suture 90 a at the other end 84 ofthe tendon 80 such that the exit point 97 a in the periphery of the endof the tendon 84 is substantially co-located with the first exit point97 of the second portion 100 of the first suture 90. The needles 92 a,93 a of the second suture 90 a are pulled out of the tendon 80 fordrawing the first and second portions 98 a, 100 a, respectively, of thesecond suture 90 a through the tendon 80 leaving a length of the secondsuture 90 a in the tendon 80 between the exit points 96 a, 97 a.

As shown in FIG. 9, the surgeon reinserts the first needle 92 of thefirst suture 90 into the periphery of the one end 82 of the tendon 80 atan entry point 102 immediately adjacent the exit point 96 and pushes theneedle 92 along a selected curvilinear path until the point 94 of theneedle 92 exits the same side of the tendon 82 at an exit point 104 thatis longitudinally spaced from the entry point 102. It is understood thatthe surgeon could use the exit point 96 as the entry point 102 for theneedle 92 if desired. The surgeon pulls the needle 92 out of the tendon82 for drawing the first portion 98 of the suture 90 through the tendon82. The surgeon may then reinsert the needle 92 into the tendon 82 at anentry point (not shown) immediately adjacent the exit point 104 and pushthe needle 92 along a selected curvilinear path and out of the same sideof the tendon 82 at an exit point (not shown) longitudinally spaced fromthe previous entry point. It is understood that the surgeon makes asmany passes as deemed necessary in a “wave-like” pattern for holding theend 82 of the tendon, or as the length or thickness of the tendon 82allows, and removes the remaining length of the first portion 98 of thesuture 90.

The surgeon repeats the steps described above with the first portion 98a of the second suture 90 a (FIG. 10) by reinserting the needle 92 ainto the tendon 82 at an entry point 102 a adjacent the exit point 96 a,crossing over the first portion 98 of the first suture 90, and pushingthe needle 92 a along a selected curvilinear path until the needle 92 aemerges from an exit point 104 a in the periphery of the tendon 82substantially co-located with the second exit point 104 of the firstportion 98 of the first suture 90. In this manner, the surgeon advanceslongitudinally along the end 82 of the tendon 80 with the first portion98 a of the second suture 90 a in a “wave-like” pattern which generallymirrors that of the first portion 98 of the first suture 90.

The previous steps are repeated at the other end 84 of the tendon 80with the second portions 100, 100 a of the first suture 90 and secondsuture 90 a. The pattern of the second portions 100, 100 a of thesutures 90, 90 a in the second end 84 of the tendon 80 generally mirrorsthat of the first portions 98, 98 a of the sutures in the first end 82of the tendon 80. Thus, the exit points and entry points of the firstand second sutures 90, 90 a are substantially co-located.

The ends 82, 84 of the tendon 80 are brought together by pushing thetendon ends along the sutures while maintaining tension on the free ends92, 92 a, 93, 93 a of the sutures 90, 90 a. The barbs 48 maintain thesutures 90, 90 a in place and resist movement of the tendon ends 82, 84away from this position. The needles along with remaining lengths of thesuture portions 98, 98 a, 100, 100 a are cut and discarded.

FIGS. 11-13 show the suture pattern resulting from use of theabove-described method of the present invention. It is understood thatwe do not intend to limit ourselves to the depth or length of the suturepaths shown in the FIGs. as the amount of tissue grasped by each pass,which is related to the depth of the suture path into the tissue and thelength of the pass from entry point to exit point, may be determined bythe surgeon based on a number of factors including the tissue to bejoined.

Another method according to the present invention for joining two ends82, 84 of a tendon 80 which is suitable for use in attaching tissue tobone is shown in FIGS. 14-17. Referring to FIG. 14, the surgeon beginsby inserting the first end 92 of a two-way barbed suture 90, which maycomprise a straight or curved surgical needle, into one end 82 of thetendon 80 and pushing the needle 92 through the tendon 82 along aselected curvilinear path until the point 94 of the needle 92 extendsfrom an exit point 96 in the periphery of the tendon 82 longitudinallyspaced from the one end 82 of the tendon. The first needle 92 is grippedand pulled out of the tendon 82 for drawing the first portion 98 of thesuture 90 through the tendon 80 leaving a length of the first portion 98of the suture in the tendon 80 between the tendon end 82 and the exitpoint 96. As seen in FIG. 14, these steps are repeated with the secondportion 100 of the suture 90 at the other end 84 of the tendon 80. Thatis, a second end 93 of the suture 90 is inserted into the tendon end 84and advanced along a selected curvilinear path to an exit point 97longitudinally spaced from the end 84 of the tendon 80. The exit point97 of the second needle 93 is on the opposite side of the tendon 80 fromthe first exit point 96 of the first portion 98 of the suture 90. Thesecond end 93 of the suture 90 projecting from the exit point 97 isgripped and pulled out of the tendon 80 for drawing the second portion100 of the suture 90 through the tendon 80 and leaving a length of thesecond portion 100 of the suture 90 in the tendon end 84 (FIG. 15).

Referring now to FIG. 15, a second suture 90 a is introduced into theends 82, 84 of the tendon 80. The first needle 92 a of the second suture90 a is inserted into the end 82 of the tendon 80 and pushed through thetendon along a selected curvilinear path until the needle 92 a extendsfrom an exit point 96 a in the periphery of the tendon 82 substantiallyco-located with the first exit point 96 of the first portion 98 of thefirst suture 90. These steps are repeated with the second portion 100 aof the second suture 90 a at the other end 84 of the tendon 80 such thatthe exit point 97 a in the periphery of the end of the tendon 84 issubstantially co-located with the first exit point 97 of the secondportion 100 of the first suture 90. The needles 92 a, 93 a of the secondsuture 90 a are pulled out of the tendon 80 for drawing the firstportion 98 a and second portion 100 a of the second suture 90 a throughthe tendon 80 leaving a length of the second suture 90 a in the tendon80 between the exit points 96 a, 97 a.

As shown in FIG. 16, the surgeon reinserts the second needle 92 a intothe periphery of the one end 82 of the tendon 80 at an entry point 102 aimmediately adjacent the exit point 96 a and pushes the needle 92 aalong a selected curvilinear path until the point 94 a of the needle 92a exits the opposite side of the tendon 82 at an exit point 104 a thatis longitudinally spaced from the entry point 102 a. It is understoodthat the surgeon could use the first exit point 96 a as the entry point102 a for the needle 92 a if desired. The surgeon pulls the needle 92 aout of the tendon 82 for drawing the first portion 98 a of the suture 90a through the tendon 82. The surgeon may then reinsert the needle 92 ainto the tendon 82 at an entry point (not shown) immediately adjacentthe exit point 104 a and push the needle 92 a along a selectedcurvilinear path and out of the opposite side of the tendon 82 at anexit point (not shown) longitudinally spaced from the previous entrypoint. It is understood that the surgeon makes as many passes in a“side-to-side” pattern as deemed necessary for holding the end 82 of thetendon 80, or as the length or thickness of the tendon end 82 allows,and removes the remaining length of the first portion 98 a of the secondsuture 90 a. With each pass, the longitudinal distance between the entrypoint and exit point decreases. The surgeon repeats these steps with thesecond portion 100 a of the second suture 90 a at the other 84 of thetendon 80. The second end 93 a of the suture 90 a is inserted into theother end 84 of the tendon 80 at an entry point 106 a immediatelyadjacent the first exit point 97 a and advanced along a selectedcurvilinear path to an exit point 108 a opposite and longitudinallyspaced from the entry point 106 a. The second portion 100 a of thesecond suture 90 a is drawn through the tendon 80 leaving a length ofthe second portion 100 a of the suture 90 a in the tendon (FIG. 17).

The surgeon repeats the steps described above with the first portion 98and second portion 100 of the first suture 90 at the ends 82, 84 of thetendon 80. As seen in FIG. 17, the needle 92 at the end of the firstportion 98 is inserted into the tendon end 82 at an entry point 102adjacent the exit point 96 and pushed along a selected curvilinear pathuntil the needle 92 emerges from an exit point 104 in the periphery ofthe tendon 82 substantially co-located with the second exit point 104 aof the first portion 98 a of the second suture 90 a. In this manner, thesurgeon advances longitudinally along the end 82 of the tendon 80 withthe first portion 98 of the first suture 90 in a “side-to-side” patternwhich generally mirrors that of the first portion 98 a of the secondsuture 90 a. Similar steps are taken with the second portion 100 of thefirst suture 90 in the other end 84 of the tendon 80. The pattern of thefirst suture 90 and second suture 90 a, as well as the respective firstportions 98, 98 a and second portions 100, 100 a of the sutures 90, 90a, generally mirror one another. The exit points and entry points of thesutures are substantially co-located. The ends 82, 84 of the tendon 80are brought together by pushing the tendon ends along the sutures whilemaintaining tension on the free ends of the sutures 90, 90 a. The barbs48 maintain the sutures 90, 90 a in place and resist movement of thetendon ends 82, 84 away from this position. The needles, along withremaining lengths of the sutures, are cut and discarded. FIGS. 18 and 19show the suture pattern using the above-described method of the presentinvention.

It is understood that more sutures may be used in any of the methods ofthe present invention. The number of sutures used depends on the size,caliber, and length of the tendon to be repaired. Large tendons willrequire more than two sutures whereas one may suffice for very smalltendons. Tendon repair with two sutures according to the presentinvention exhibits equivalent or better holding power than conventionaltechniques. Moreover, tendons repaired according to the methods of thepresent invention maintain their original configuration, profile,contour, and form better when subject to stretching forces. Othermethods of tendon repair suitable for use according to the presentinvention are shown and described in U.S. patent application Ser. No.09/896,455, entitled “Suture Method”, which was filed on Jun. 29, 2001,the contents of which are hereby incorporated by reference.

FIGS. 20 and 21 are two views of the Achilles tendon 74 reattached tothe heel bone 76 to promote healing according to the present inventionusing the suture method shown in FIGS. 7-13. The tendon 74 and bone 76will, over time, grow together.

The present invention provides a compact and easy to use suture anchorand method for reattaching tissue, such as tendons and ligaments, tobone or other connective tissue. The curvilinear placement paths of thesuture portion, as contrasted with linear insertion, providesubstantially increased biomechanical strength for approximating tissueand bone, or the ends of tendon. The barbed suture portion permitstissue to be approximated and held snug during suturing with lessslippage of the suture in the wound. The barbs spread out the holdingforces evenly thereby significantly reducing tissue distortion. Thesuture anchor is useful in endoscopic and arthroscopic procedures andmicrosurgery. Since knots do not have to be tied, arthroscopic knottying instruments are unnecessary. If there is an accidental breakage ofthe barbed suture, the wound is minimally disturbed whereas, withconventional sutures, dehiscence would occur.

Although the present invention has been shown and described inconsiderable detail with respect to only a few exemplary embodimentsthereof, it should be understood by those skilled in the art that we donot intend to limit the invention to the embodiments since variousmodifications, omissions and additions may be made to the disclosedembodiments without materially departing from the novel teachings andadvantages of the invention, particularly in light of the foregoingteachings. For example, the methods of the present invention can be usedwith a suture anchor alone as a two-way barbed suture. Accordingly, weintend to cover all such modifications, omissions, additions andequivalents as may be included within the spirit and scope of theinvention as defined by the following claims.

1. A suture system adapted to be positioned in tissue comprising: aplurality of sutures, each suture having a first end and a second end; abody located between the first ends and the second ends of saidplurality of sutures; a first plurality of barbs located on each of saidsuture of the plurality of sutures between the body and the first end;each of said first plurality of barbs oriented so as to permit movementof the suture in a direction of movement of the first end through tissueand prevent movement of the suture in a direction of movement of thesecond end through tissue; a second plurality of barbs located on eachof said suture of the plurality of sutures between the body and thesecond end; each of said second plurality of barbs oriented so as topermit movement of the suture in a direction of movement of the secondend through tissue and prevent movement of the suture in a direction ofmovement of the first end through tissue; and said body connectingtogether said sutures of said plurality of sutures.
 2. The system ofclaim 1 wherein: said body is slidably located on said sutures.
 3. Thesystem of claim 1 wherein: said body has an opening and said sutures canslide through said opening.
 4. The system of claim 1 wherein: said bodyhas a first opening and a second opening and said sutures can slidthrough both said first opening and said second opening.
 5. The systemof claim 1 wherein: said body is cylindrical.
 6. The system of claim 1wherein: said body is a three-dimensional body.
 7. The system of claim 1wherein: said body includes a bio-absorbable material.
 8. The system ofclaim 1 wherein: said body includes at least one of ridges, barbs andserrations.
 9. The system of claim 1 wherein: the body has a circularcross-section.
 10. The system of claim 1 wherein: said body includes anopening and said sutures can move relative to said opening.
 11. Thesystem of claim 1 wherein: said body is cone shaped.
 12. The system ofclaim 1 wherein: said body is wider than any of said sutures.
 13. Thesystem of claim 1 wherein: said body includes an outer surface that canengage and hold tissue.
 14. The system of claim 1 wherein: said body hasan outer surface that can hold tissue.
 15. The system of claim 1wherein: said body is wider than any of said sutures and said body hasan outer surface that can hold tissue.
 16. The system of claim 1wherein: said body includes a first material and said sutures includes asecond material; and said first material is different than said secondmaterial.
 17. The system of claim 1 wherein: said first end of eachsuture is pointed and said second end of each suture is pointed; and thefirst pointed ends point away from the body; and the second pointed endspoint away from the body.
 18. The system of claim 1 wherein: said firstends extend away from said body and said second ends extend away fromsaid body.
 19. A suture system adapted to be positioned in tissuecomprising: a plurality of sutures, each suture having a first end and asecond end; a body located between the first ends and the second ends ofsaid plurality of sutures; a first plurality of barbs located on eachsaid suture of the plurality of sutures between the body and the firstend; each of said first plurality of barbs oriented so as to permitmovement of the suture in a direction of movement of the first endthrough tissue and prevent movement of the suture in a direction ofmovement of the second end through tissue; a second plurality of barbslocated on each said suture of the plurality of sutures between the bodyand the second end; each of said second plurality of barbs oriented soas to permit movement of the suture in a direction of movement of thesecond end through tissue and prevent movement of the suture in adirection of movement of the first end through tissue; and said bodyconnecting together said sutures of said plurality of sutures; and saidbody is slidably located on said sutures.
 20. A suture system adapted tobe positioned in tissue comprising: a plurality of sutures, each suturehaving a first end and a second end; a body located between the firstends and the second ends of said plurality of sutures; a first pluralityof barbs located on each said suture of the plurality of sutures betweenthe body and the first end; each of said first plurality of barbsoriented so as to permit movement of the suture in a direction ofmovement of the first end through tissue and prevent movement of thesuture in a direction of movement of the second end through tissue; asecond plurality of barbs located on each said suture of the pluralityof sutures between the body and the second end; each of said secondplurality of barbs oriented so as to permit movement of the suture in adirection of movement of the second end through tissue and preventmovement of the suture in a direction of movement of the first endthrough tissue; and said body connecting together said sutures of saidplurality of sutures; and said body is slidably located on said sutures;and said body has an opening and said sutures can move relative to saidopening.